Recruiting

Genicular Artery Embolization

Sponsor:

University of Chicago

Code:

NCT06781463

Conditions

Knee Osteoarthritis

Knee Osteoarthritis (Knee OA)

Knee Osteoarthritis (OA)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Registry (N/A)

Study Details

Brief summary:

The goal of this study is to create a prospective registry (<100 patients) to show the effectiveness of the genicular artery embolization procedure overtime in reducing bilateral or unilateral osteoarthritic knee pain as measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.

Conditions

Knee Osteoarthritis

Knee Osteoarthritis (Knee OA)

Knee Osteoarthritis (OA)

Study ID

NCT06781463

Start date

Oct 1, 2023

Status verified date

May, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients aged >=18
  • Bilateral or unilateral knee pain attributed to knee osteoarthritis (KOA). For bilateral KOA patients, the more severe knee will be permitted inclusion to the registry
  • Grade 1-3 Osteoarthritis as diagnosed on standing weight-bearing knee radiographs per the Kellen-Lawrence Grading scale
  • Knee pain >6 months refractory to conservative medical management (Nonsteroidal anti-inflammatory drugs, acetaminophen, etc.)
  • Not eligible for surgical knee replacement or patient's personal preference to undergo Genicular Artery Embolization (GAE) for reasons such as minimally invasiveness of GAE

Exclusion Criteria:

  • Active malignancy
  • Active infection of the affected knee
  • Platelets <50,000/uL, INR >2.0 (unless on anticoagulation that can be reversed or performing radial/pedal access without reversal)
  • Corticosteroid injection of the affected knee within 3 months of enrollment
  • Rheumatoid arthritis or other seronegative arthropathy
  • Previous surgery (excluding arthroscopy) of the affected knee
  • Grade 4 per Kellgren-Lawrence Grading Scale of the affected knee
  • Pregnancy or expected pregnancy
  • Glomerular Filtration Rate (GFR) <30
  • Anaphylactic reaction to iodinated contrast
  • Moderate to severe pain in other lower limb joints
  • Body weight >400 lbs. (prohibiting safe angiography)
  • Peripheral arterial disease of the treated extremity (Rutherford Grade 2 or greater)

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Registry

Since this is a registry all enrolled patients are part of one group and will be followed for one year from the respective date of procedure.

Interventions

Registry (N/A)

This study is a registry, thus no research intervention is being directly tested.

Primary outcome measure

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 1 year of enrollment/patient ]

Central Contacts and Locations

Central contacts

Tiana Jackson

773.795.7030Tiana.Jackson@bsd.uchicago.edu

Patrick Tran, Doctor of Medicine

626-807-1545Patrick.tran@bsd.uchicago.edu

Locations

University of Chicago Duchossois Center for Advanced Medicine

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Natasha Rodwell, Bachelor of Science in Nursing

773-926-8458natasha.rodwell-maxon@uchicagomedicine.org

Jordan Olsen, Bachelor of Science

218-461-2112jordan.olsen@bsd.uchicago.edu

Principal Investigator:

Patrick Tran, Doctor of Medicine

More Information

Sponsor

University of Chicago

Last update posted

May 13, 2026

Last verified

May, 2026

Keywords

  • knee pain
  • knee replacement alternative
  • knee arthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-05-13.